The fundamental tenet of the 510k process is a demonstration of substantial equivalence. To be considered substantially equivalent a device is required, in comparison to a predicate to:
• have the same intended use as the predicate; and
• have the same technological characteristics as the predicate;
or
• have the same intended use as the predicate; and
• have different technological characteristics and the information submitted to FDA;
Intended use is therefore the fundamental of substantial equivalence.
So,
When a manufacturer wishes to change the intended use of a device, particularly where that change is a modification from a Prescription Use to an Over-the-Counter (OTC) use, which the guidance declares is considered a major change requiring submission of a new 510k.
If in those circumstances no predicate using the modified OTC intended use exists how does the manufacturer satisfy the fundamental tenet we identified above?
Or is the answer simply, you can’t you need to submit a PMA?
Anyone care offer an opinion? all welcomed.
• have the same intended use as the predicate; and
• have the same technological characteristics as the predicate;
or
• have the same intended use as the predicate; and
• have different technological characteristics and the information submitted to FDA;
o does not raise new questions of safety and effectiveness; and
o demonstrates that the device is at least as safe and effective as the legally marketed device.
o demonstrates that the device is at least as safe and effective as the legally marketed device.
Intended use is therefore the fundamental of substantial equivalence.
So,
When a manufacturer wishes to change the intended use of a device, particularly where that change is a modification from a Prescription Use to an Over-the-Counter (OTC) use, which the guidance declares is considered a major change requiring submission of a new 510k.
If in those circumstances no predicate using the modified OTC intended use exists how does the manufacturer satisfy the fundamental tenet we identified above?
Or is the answer simply, you can’t you need to submit a PMA?
Anyone care offer an opinion? all welcomed.
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